Importing Pharmaceutical Products: What Every Importer of Drugs and APIs Should Know

Why Should You Attend:

This webinar will focus on U.S. import requirements for drugs and APIs. Attendees will learn about the entry process and the various regulatory agencies that share jurisdiction over the import of drugs and APIs. On completing this course, attendees will be familiar with HTS classification for these pharmaceutical products, customs bonds and documentation requirements, in addition to gaining an understanding of FDA import requirements such as proper use of FDA product codes and affirmation of compliance codes. The requirements for importing investigational and research products will also be highlighted.

Learning Objectives:

After completing the webinar, attendees will be able to:

• Know how the U.S. entry process for pharmaceutical products works
• Know FDA import requirements for pharmaceutical products
• Learn strategies to avoid unnecessary clearance delays

Areas Covered in the Webinar:

• Import entry compliance
• Import documentation
• Custom bond requirements
• HTS classification for drugs and API
• Special duty rates and programs for pharmaceutical products
• FDA product codes
• FDA Affirmation of Compliance codes
• Importing investigational and research products (both clinical and non-clinical)
• Participating Government Agency (PGA) requirements

Who Will Benefit:

• Employees from companies engaged in international trade of pharmaceutical products
• U.S. importers of pharmaceutical products
• Pharmaceutical sponsors and investigators importing clinical drugs into the U.S
• Purchasing department staff of health industry
• Compliance officers
• Logistics/supply chain managers and analysts
• Trade regulatory/legislative affairs professionals
• Sales/marketing personnel
• Training personnel
• Consultants
• International business operations

Instructor Profile:

Reynaldo Roman is a licensed U.S. customs broker and certified customs specialist with two decades of experience in customs brokerage and U.S. trade compliance. During his career, Mr. Roman has managed customs’ brokerage teams, worked as a compliance analyst at a large international importer and completed high-level trade compliance assignments such as product line classification and customs protest and duty refund projects. He has gained specialized knowledge in the areas of pharmaceutical and medical devices, cosmetics and food products and other regulated products.

In his current role, as senior manager of trade compliance at Marken, an international clinical logistics organization providing logistical services to the pharmaceutical and clinical research companies, Mr. Roman supports operational teams and clients by ensuring compliance with trade and regulatory requirements of customs and other government agencies.

Topic Background:

One of the FDA’s key activities is to monitor the import of regulated products in order to verify that these products meet U.S. import standards and requirements. Therefore, companies and individuals are responsible for notifying FDA whenever they import a regulated product. In addition to notifying FDA, importers are also legally responsible for using reasonable care when describing, classifying and declaring the value of the products they import and for complying with any other applicable import regulations.

The Federal Food and Cosmetic Act (FD&C) grants the FDA with the authority to refuse the entry of products found to be in violation of the Act. Forcing importers of such products to export or destroy the products at the importer’s expense. In addition, importers of violative products may be subject to administrative and/or monetary penalties for failure to comply with import requirements.

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